FDA.reportPublic FDA data

Nighttime Cold and Cough

Manufacturer
Best Choice (Valu Merchandisers Company)
Effective date
2024-02-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:47

Label at a glance#

ProductNighttime Cold and Cough childrens
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritations as may occur with a cold

Dosage and administration

do not give more than 6 doses in 24 hours unless directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter shake well before using Age Dose  children 6 to under 12 years of age  10 mL every 4 hours children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years  do not use 

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves
    • sneezing
    • runny nose
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritations as may occur with a cold

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in a child under 4 years of age
  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI,  ask a doctor or pharmacist before giving this product.
  • with any other product containing diphenhydramine, even one used on skin
  • for the purpose of making your child sleepy

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product,

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give more than 6 doses in 24 hours unless directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL= milliliter
  • shake well before using
AgeDose 
children 6 to under 12 years of age 10 mL every 4 hours
children 4 to under 6 years of agedo not use unless directed by a doctor
children under 4 years do not use 

Other Information

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 3 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children's Triaminic® Night Time Cold & Cough

Children's Triacting Night Time Cold & Cough

Diphenhydramine HCl 6.25 mg

Antihistamine / Cough Suppressant

Phenylephrine HCl 2.5 mg

Nasal Decongestant

Multi-symptom relief

  • Cough
  • Runny, stuffy nose
  • Itchy throat

For Ages 6 to 11 years

Alcohol-free

Grape Flavor

FL OZ (mL)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Children's Triaminic® Night Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5000 KANSAS AVE, KANSAS CITY, KS 66106

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BEST CHOICE Children's Triacting Night Time Cold & Cough Grape Flavor
BEST CHOICE Children's Triacting Night Time Cold & Cough Grape Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1236048diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN2
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD2
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY2
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-984-04Nighttime Cold and Coughchildrens1 in 1 BOXLIQUID12
63941-984-04Nighttime Cold and Coughchildrens118 mL in 1 BOTTLE, PLASTICLIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-984NIGHTTIME COLD AND COUGH CHILDRENS (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2Current NDC, Legacy NDC, 2 package rows20240221_11652e8a-2242-4449-8a41-a8e75509025e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63941-98463941-984-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and Cough childrensDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)11652e8a-2242-4449-8a41-a8e75509025e2024-02-20WarningsExact identifier
ndc (package): 63941-984-04
ndc (product): 63941-984
ndc11 (package): 63941098404
spl id: 6cdf3375-14c8-4484-a447-69daab0a42b9
spl set id: 11652e8a-2242-4449-8a41-a8e75509025e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.